XBiotech cancer treatment flunks FDA panel

April 21, 2017

Shares of XBiotech Inc. XBIT, -39.89% plummeted 30% in premarket trade Friday, after the biosciences company indicated its cancer treatment’s marketing application would not be recommended by a European review panel. The company said late Thursday that the European Medicines Agency (EMA) rendered a negative “trend” vote related to XBiotech’s marketing authorization application for its antibody candidate for the treatment of colorectal cancer, with the key outstanding issue related to clinical relevance of the therapy. A negative trend vote suggests it is unlikely that the Committee for Medicinal Products for Human Use will give a positive opinion at the formal decision vote scheduled in May. It means additional steps will likely be needed to gain marketing approval. “We are disappointed by the outcome of the meeting. We believe that the data speak in a clear and resounding voice to clinical relevance of a new antibody therapy in advanced colorectal cancer,” said Chief Executive John Simard. The stock had rocketed 68% year to date through Thursday, while the iShares Nasdaq Biotechnology ETF IBB, -0.98% had climbed 9.4% and the S&P 500 SPX, -0.30% had gained 5.2%.